Biocartis BE0974281132

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1. DRTVR 15 september 2020 11:44

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   Die corona-aandelen stijgen even snel als ze dalen hoor. Maar inderdaad daar gebeurd het tenminste :p
   Kan je die 50% nog pakken (Vaxart)
   
   Had even Kiadis int oog met zijn net verkregen subsidie in de VS.
2. Matsversch 15 september 2020 12:31

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   quote:

   DRTVR schreef op 15 september 2020 11:44:

   Die corona-aandelen stijgen even snel als ze dalen hoor. Maar inderdaad daar gebeurd het tenminste :p
   Kan je die 50% nog pakken (Vaxart)
   
   Had even Kiadis int oog met zijn net verkregen subsidie in de VS.
   

   ja ziet er interessant uit,
   Ook hoger koersdoe gekregen bij enkele.
   Ik ga het ook eens volgen
3. [verwijderd] 15 september 2020 17:27

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   Het is vandaag weer huilen met de pet op.
4. MisterBlues 15 september 2020 23:21

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   How ‘Tumor On A Chip' Can Transform Drug Development - New Research From Draper And Charles River Labs Offers Answers
   Novel device gives cancer researchers and testing labs a tumor environment that can reduce testing from weeks to days.
   
   Cambridge, MA (PRWEB) - Animal models have long been the standard in drug development and cancer research. Now, a team of engineers has developed a test bed that creates just the right conditions for testing on tumor tissue in real-time. The impact could be significant for cancer researchers and drug developers interested in translating scientific findings into practical clinical applications, such as cancer therapies, sooner.
   
   The team, led by Draper, tested the device, called EVIDENT, to see if they could suppress tumor growth using a type of immunotherapy called immune checkpoint inhibitor (ICI) equally well in a living mouse as on a mouse tumor tissue residing in the EVIDENT device.
   
   ICIs have shown remarkable success against melanoma, non-small-cell lung cancer and Hodgkin’s lymphoma. The new approach is described in the peer-reviewed archival International Journal of Molecular Sciences, written by Jeff Borenstein, Vienna Mott and Cassie Bryan of Draper, John Ho and Julia Schueler of Charles River Laboratories and Daniel Doty and Nathan Moore, both formerly of Draper.
   
   “We found excellent correlations between in vivo syngeneic mouse model and in vitro tumor biopsy responses to checkpoint inhibitors,” the authors said. “Here we demonstrate for the first time that a dynamic tumor microenvironment can distinguish differences between two different ICI therapies, anti-CTLA4 and anti-PD-1, against three different syngeneic mouse lines, MC38, CT26 and B16F10.”
   Models recapitulating the tumor microenvironment have been in development for more than a decade. But they are typically static systems that do not capture the dynamics of lymphocyte migration and drug transport, and they are limited to a very short experimental duration due to the rapid decline in tissue viability, typically within 24 to 72 hours.
   
   “An urgent need exists for engineered platforms capable of supporting viable tumor fragments for periods of a week or longer,” Borenstein said. “Our tests show that EVIDENT can accommodate dynamic interactions between lymphocytes and tumors and is compatible with real-time imaging and quantification of tumor killing and lymphocyte infiltration in response to ICI treatments.”
   
   While it’s likely that animals will continue to play a key role in drug development, researchers are now trialing new treatments and, with platforms like EVIDENT, can opt to augment trials with tissue, including potentially human tumor tissue, that can be tested in real time.
   
   “The main advantage to EVIDENT is speed and throughput, since we obtain an answer in seven days as compared to six weeks in a mouse, and we can run 12 experiments in EVIDENT versus one in a mouse,” Mott explained. “The other advantage is that we can observe mechanisms—minute-by-minute, if required—in an in vitro system that cannot be observed in a living animal.”
   Julia Schueler, Research Director at Charles River Laboratories, said, “The EVIDENT platform is a valuable asset to oncology drug development because it has the potential to enable faster investigational new drug (IND) filings, as well as supporting animal welfare as an important contribution to the 3Rs principle (replace, reduce and refine).”
   
   EVIDENT stands for Ex Vivo Immuno-oncology Dynamic ENvironment of Tumor biopsies. The system features organ-on-a-chip technology, flow-control using a single pump, low-absorption materials and the ability to connect to Draper’s customizable image analytic algorithms to provide automated and quantitative assessment of experimental results. EVIDENT enables cancer researchers to evaluate how ICIs and other drugs arm the immune system to kill tumors in a high-throughput, scalable configuration.
   
   Charles River provided the materials used in the research.
   Source: PRWeb
   View original release here:
   
   Model.Doc.OriginalUrl
   
5. Flatlander 16 september 2020 06:31

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   Impact of COVID on MDx Testing Webinar
   
   www.diaceutics.com/316ab81f-0716-4040...
   
   It is an hour long. You might have sign in but it is free.
   
   Slides 12 and 28 are encouraging to hear (as a BCART shareholder). China is moving toward decentralized MDx as NGS volumes are down (resulting in higher costs). What could be more decentralized than Idylla?
   
   Slide 28 is their projected demand increase for next year as delayed Oncology MDx represents itself with more severe cancer cases on top of lab capacity that is stretched by COVID.
   
   A lot of moving parts but it is consistent with some of the thoughts I've espoused about the pandemic potentially accelerating Idylla use as lab capacity is taken up by COVID testing.
   
   Also, some interesting insights on the number of biomarkers that will enter the market and that it may take up to 4.5 years for a CDx.
   
   FL
   
6. CGCDLR 16 september 2020 10:47

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   15 september 2020
   Immuunexpress presenteert gegevens voor klinische validatie van SeptiCyte@Rapid voor diagnose van Sepsis op e-ISISEM.Doorbraak?
7. Matsversch 16 september 2020 10:52

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   quote:

   CGCDLR schreef op 16 september 2020 10:47:

   15 september 2020
   Immuunexpress presenteert gegevens voor klinische validatie van SeptiCyte@Rapid voor diagnose van Sepsis op e-ISISEM.Doorbraak?
   

   Hopelijk, maar telkens met goed nieuws dropt dit aandeel gelijk de dag erna weer naar 4,7.
   Wil eens wat vooruitgang zien
8. Flatlander 16 september 2020 15:50

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   MB
   
   Certainly a technology to keep an eye on. Rudi Pauwels was working with John's Hopkins on a similar technology. Yes there may be footsteps of these oncoming technologies. However, I'm unaware of any head to head comparisons with PCR or NGS. This is one big reason to press for IVD registrations in a timely manner. So much of BCART'S potential is tied to deploying a large & growing user base.
   
   Regards
   FL
9. Flatlander 16 september 2020 22:32

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   False positives in the Danaher Rapid Covid test used in nursing homes. While I believe that BCARTs future is in oncology MDx. There is a lot of evidence that some of the Fast TAT tests have problems (Abbot ID Now..). If BCART can demonstrate reliability it has a chance to gain some recognition.
   FL
   
   www.genomeweb.com/scan/reports-rapid-...
10. stoppelbaard 17 september 2020 13:54

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    quote:

    Matsversch schreef op 16 september 2020 10:52:

    [...]
    
    Hopelijk, maar telkens met goed nieuws dropt dit aandeel gelijk de dag erna weer naar 4,7.
    Wil eens wat vooruitgang zien
    

    ben het met U eens, bij goed nieuws is er kortstondig een ruk(je) naar boven te merken, maar gelijk daarna nemen de shorters hun positie weer in, ik geloof dat dit aandeel erg bekend is onder de shorters, kan niet zeggen hoeveel % (maar uit herinnering >5 %).
    Blijf het doodzonde vinden, geloof ook in het potentieel maar dat moet er nu toch eens gaan úitkomen.... en niet alleen door meer cartridges te verkopen, ook artikels die aantonen/beschrijven wat een meerwaarde deze snelle responstijd brengt... maw meer communicatie.
11. [verwijderd] 17 september 2020 17:44

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    quote:

    stoppelbaard schreef op 17 september 2020 13:54:

    [...]
    ben het met U eens, bij goed nieuws is er kortstondig een ruk(je) naar boven te merken, maar gelijk daarna nemen de shorters hun positie weer in, ik geloof dat dit aandeel erg bekend is onder de shorters, kan niet zeggen hoeveel % (maar uit herinnering >5 %).
    Blijf het doodzonde vinden, geloof ook in het potentieel maar dat moet er nu toch eens gaan úitkomen.... en niet alleen door meer cartridges te verkopen, ook artikels die aantonen/beschrijven wat een meerwaarde deze snelle responstijd brengt... maw meer communicatie.
    

    Het is spijtig dat haast enkel kbc bank enkel wat te vertellen heeft als Biocartis met een PB komt.
    Moest Biocartis een notering op de nasdaq hebben zouden ze van veel meer belangstelling van gerenomeerde analisten kunnen genieten.
12. Stockbrood 17 september 2020 19:08

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    quote:

    stoppelbaard schreef op 17 september 2020 13:54:

    [...]
    ben het met U eens, bij goed nieuws is er kortstondig een ruk(je) naar boven te merken, maar gelijk daarna nemen de shorters hun positie weer in, ik geloof dat dit aandeel erg bekend is onder de shorters, kan niet zeggen hoeveel % (maar uit herinnering >5 %).
    Blijf het doodzonde vinden, geloof ook in het potentieel maar dat moet er nu toch eens gaan úitkomen.... en niet alleen door meer cartridges te verkopen, ook artikels die aantonen/beschrijven wat een meerwaarde deze snelle responstijd brengt... maw meer communicatie.
    

    Al 90 dagen nagenoeg geen verandering in short posities dus uw theorie lijkt niet te kloppen. De positie van citadel europe is ook al meermaals de revue gepasseerd. Ongeacht positief of negatief nieuws, blijft deze constant. Vermoeden is dat dit een hedge is op hun longpositie via de convertibles.
    
    shortsell.nl/short/Biocartis
    
    Bcart is allesbehalve een speelbal van shorters. Er zijn gewoon heel veel beleggers die er genoeg van hebben en bij elke stijging zijn er weer mensen die hun zitje op het schip verkopen... Zakken gebeurt vaak op laag volume.
    
    Stock
    
    
13. Flatlander 17 september 2020 23:46

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    I agree with the Citadel convertible arbitrage strategy, but then again I think I'm the one that initially speculated that was the case. I think there is little follow through on any good news because BCART is a very opaque stock. As I pointed out a week or two ago, we have yet to see any positive partnership announcement, technical paper or presentation translate to increased cartridge sales or console placements. So, to date there is no historical reason to project any news to the top or bottom lines. In the absence of any such relationship between good news and financials, some investors take any upward move as a chance to sell on the uptick. I think they may be betting that the company does another capital raise early next year and they are betting that there will not be any positive share price moving news between now and then.
    
    Sometimes, to my own detriment I try to be an optimist despite evidence to the contrary. I believe that one of these days BCART will show some follow through. For instance, an announcement of full IVD registration in a new geographic area and a major placement of a large number of instruments (Possibly Japan/ Nichirei Bioscience could be right around the corner).
    
    Has anyone listened to the Webinar link I posted a couple days ago? They project that next year will be very pivotal in MDx testing. The number of delayed routine screenings (colonoscopies, lumpectomies, lung, etc) will translate to more cases of progressed disease on top of labs burdened by COVID testing workload. Biomarkers are a major tool used by physicians to stratify patients into treatment groups (chemo, oral meds, etc). The need for reliable faster TAT MDx data could increase greatly.
    
    China was 1st into this pandemic and they are already showing a pronounced shift toward decentralized testing (especially in 2nd tier cities). Some of the speakers projected that the U.S. and the EU will move in a similar direction. This could be a very positive environment for Idylla. Of course as always, this is contingent on gaining access to the diagnostic markets in more geographies. Cepheid often benefited from expedited approvals during feared outbreaks. Perhaps constrained lab capacity will act to expedite Idylla approvals.
    
    FL
    
    
14. Flatlander 18 september 2020 00:26

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    Novacyt firing on all cylinders. Although, I think their undisclosed distribution partner is Fisher. Hopefully that goes better for them than it did for BCART. Novacyt is primarily a COVID play but their Primerdesign group is active in a variety of new diagnostic products.
    
    FL
    
    www.genomeweb.com/molecular-diagnosti...
15. [verwijderd] 18 september 2020 09:56

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    quote:

    stoppelbaard schreef op 17 september 2020 13:54:

    [...]
    ben het met U eens, bij goed nieuws is er kortstondig een ruk(je) naar boven te merken, maar gelijk daarna nemen de shorters hun positie weer in, ik geloof dat dit aandeel erg bekend is onder de shorters, kan niet zeggen hoeveel % (maar uit herinnering >5 %).
    Blijf het doodzonde vinden, geloof ook in het potentieel maar dat moet er nu toch eens gaan úitkomen.... en niet alleen door meer cartridges te verkopen, ook artikels die aantonen/beschrijven wat een meerwaarde deze snelle responstijd brengt... maw meer communicatie.
    

    Het is Thrump en zijn ploeg,
    hij zegt toch,
    "als ik niet herkozen wordt, dalen de beurzen."
    
    :)
    Amerika furst
    :)
    Ze kunnen dan alles goedkoop opkopen
    :)
    
16. brightlight 18 september 2020 15:55

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    quote:

    Carter schreef op 9 september 2020 11:55:

    In de conference call maakt Herman Verrelst duidelijk dat de EUA ingediend is op 10 augustus.
    Later in de Q&A session verklaart hij dat bij gelijkaardige indieningen een periode van 4 tot 6 weken
    verstrijken vooraleer goedkeuring. Dus het timeframe klopt met het ISICEM en eventuele aankondiging door immuneexpress.
    Spannend!
    

    Als dat zo is, dan moet dat vandaag gebeuren. Ik veronderstel hun hun tweede presentatie op dit congres vandaag gebeurt? In ieder geval, FDA goedkeuring van Septicyte Rapid wordt verwacht in Q3. Nog 8 dagen voor het einde van Q3. Lang kan het niet meer duren, denk ik dan.
17. Flatlander 18 september 2020 17:26

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    BL
    
    Immunexpress has pushed their guidance for Septicyte Rapid validation study in the US to the 4th quarter (i.e., before the end of the year). I thought I had posted that previously. I attended the SCCM webinar and asked a couple questions. There was a false positive (high Septiscore in the healthy non COVID population) and a false negative (lower septiscore in the intubated severe COVID population). The answer for the false negative is that intubation does not necessarily equate to sepsis. There could be another factor (i.e., COPD etc.) that is hindering breathing/oxygen exchange without sepsis being present. The false positive is more confusing and a much larger population is required to assess the significance. The encouraging point was that the high septiscore upon ER admission in one of the cases correlated to very severe COVID/Sepsis suggesting it may provide the desired early indication.
    
    Long story short the above complexities of the results will take a few more months to resolve in the validation studies. Immunexpress indicated some frustration that the validation studies were limited to publicly available data. They cannot find out what comorbidities each patient had or what drugs they might be on, or access full blood workup results etc. As such, they have had to utilize a computer modeling algorithm (i.e., en-silica) to assess the likeyhood of sepsis being present. The EU rollout ahead of the US may help with freeing up data from independent investigators that have access to all the patient data (blood analysis results etc.). I'm hopefully of independent investigator research papers emerging early next year. I'm still very optimistic about septicyte rapid but once again we have to wait for the validation. The EU rollout of Septicyte Rapid is probably occurring already. I expect an announcement on the EU and US EUA for the COVID assay any day.
    
    FL
18. brightlight 18 september 2020 21:39

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    quote:

    Flatlander schreef op 18 september 2020 17:26:

    BL
    
    Immunexpress has pushed their guidance for Septicyte Rapid validation study in the US to the 4th quarter (i.e., before the end of the year). I thought I had posted that previously. I attended the SCCM webinar and asked a couple questions. There was a false positive (high Septiscore in the healthy non COVID population) and a false negative (lower septiscore in the intubated severe COVID population). The answer for the false negative is that intubation does not necessarily equate to sepsis. There could be another factor (i.e., COPD etc.) that is hindering breathing/oxygen exchange without sepsis being present. The false positive is more confusing and a much larger population is required to assess the significance. The encouraging point was that the high septiscore upon ER admission in one of the cases correlated to very severe COVID/Sepsis suggesting it may provide the desired early indication.
    
    Long story short the above complexities of the results will take a few more months to resolve in the validation studies. Immunexpress indicated some frustration that the validation studies were limited to publicly available data. They cannot find out what comorbidities each patient had or what drugs they might be on, or access full blood workup results etc. As such, they have had to utilize a computer modeling algorithm (i.e., en-silica) to assess the likeyhood of sepsis being present. The EU rollout ahead of the US may help with freeing up data from independent investigators that have access to all the patient data (blood analysis results etc.). I'm hopefully of independent investigator research papers emerging early next year. I'm still very optimistic about septicyte rapid but once again we have to wait for the validation. The EU rollout of Septicyte Rapid is probably occurring already. I expect an announcement on the EU and US EUA for the COVID assay any day.
    
    FL
    

    FL
    
    Thanks for clarifying. I did read your September 12 post. It was not entirely clear to me. The way I understood it was that the Septicyte Rapid test was (additionally) being validated for Covid 19 triage (on top of an earlier Sepsis triage validation study) and that the false positive and negative were related to that Covid triage validation study. I thought the validation studies of Rapid for Sepsis triage were already finished and that based on those studies the EU approval was obtained and the US was to follow. Hearing now that a validation study for approval in the US is still ongoing is new to me. Must have missed it. Have not been following the Bcart news very closely the last few months. Of course now it makes sense. Linking Rapid to Covid triage was probably the only way to get EUA.
    
    On your second point, why do you think the announcement for the Covid assay will arrive any day now? Do you have info on when the application was submitted and how long it typically takes to get approval? Or is it just a gut feeling?
    
    BL
19. CGCDLR 18 september 2020 22:01

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    Esmo congres (19-21sept.).Misschien help3dit ons een stap vooruit.
20. Flatlander 18 september 2020 22:24

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    BL
    
    The part of the validation showing that Septicyte Rapid is equivalent to Septicyte Lab has been completed. Depending on the Lab, I've seen R2 values ranging from 94% to 97%. The minimal variation is probably Septicyte Lab operator procedure related. This was probably the basis for the EU approval of Septicyte Rapid. One would think it would be adequate in the U.S as well, since Septicyte Lab has been approved since 2017. The trials that resulted in the 2017 approval of Septicyte Lab included sepsis resulting from viral infections. This approval should have been broad enough to encompass COVID, leaving it up to the user to develop a comfort for each individual virus or bacterial infection. The FDA and BARDA have gone beyond, presumably as part of the effort to fight the pandemic and required validation for the COVID virus triage, specifically.
    
    My optimism of a COVID EUA approval announcement any day is based on Verrelsts' comments during the Sept 4 call. If they filed for EU and FDA EUA on or around Aug 10, the approvals have emergency use authorizations have been taking less than 6 weeks. The fact that this test was developed on top of the JnJ RSV platform which previously received 510K approval should act to expedite approval (one would think).
    
    Finally, there are a ton approvals for COVID testing.
    
    www.360dx.com/coronavirus-test-tracke...
    
    Looking at the early approvals relative to the start of the pandemic, it looks like approvals were received quite quickly. However, recently there has been backlash over erroneous test results in some of the nursing home IVDs. Since the nursing homes have been using the rapid POC tests to determine populations that should be isolated from the healthy population, wrong answers can have dire consequences. This could result in increased review timeframes.
    
    Have a good weekend.
    
    FL